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WASHINGTON, Feb. 5, 1998 – Despite Food and Drug Administration claims to the contrary, defense health officials said the use of a vaccine against tickborne encephalitis given to soldiers in Bosnia in 1996 was safe and effective.
Nearly 4,000 American soldiers at high risk volunteered for vaccinations after being briefed on the drug's European history. Some 27 million doses of the vaccine have been given in Europe, where several countries have approved its use. The soldiers signed consent forms before receiving a three-shot series. Subsequently, there have been no verifiable cases of tickborne encephalitis among U.S. soldiers in Bosnia. In a July 22, 1997, letter to DoD, FDA Commissioner Michael Friedman contended the vaccinations placed the soldiers at risk and violated FDA guidelines for the use of experimental drugs. Defense officials admitted faulty recordkeeping, but noted the drug was administered under FDA investigational new drug guidelines. Officials said the vaccine was necessary because tickborne encephalitis is endemic to the region and no recognized medical alternative exists. Encephalitis causes inflammation of the brain, leading to paralysis and death. The Army Medical Research and Materiel Command at Fort Detrick, Md., assessed the vaccine's safety and effectiveness before it was administered to soldiers. The department also has held extensive discussions with the FDA to develop options for allowing DoD to use the best available products to protect deployed soldiers against medical threats and to adapt recordkeeping and other administrative requirements to the operational setting, officials said. However, they admitted a small number (14) of the consent forms were misplaced, as were 242 unused doses of the vaccine. In his letter, Friedman criticized DoD for shortfalls and "significant deviations" in its administration of the vaccine. The letter also renewed criticism of the military's administration of investigational new drugs during the Persian Gulf War. In a letter countering Friedman's criticism, Lt. Gen. Ronald Blanck, Army surgeon general, said the vaccination "was given safely" in Bosnia. The Army ended the vaccination program in September 1997 after no cases of tickborne encephalitis occurred among U.S. troops in Bosnia. Meanwhile, the service adopted environmental control measures and taught the soldiers to take precautions against the disease through proper wear of the uniform; treating their skin and uniforms with approved tick repellents; and other measures.
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